Senior Engineer, Manufacturing

The primary objective of the role is to drive improvement towards operational excellence by leveraging Lean and Six Sigma principles in the manufacturing site's processes as well as building continuous improvement mindset and culture within the site. Through the application of industrial engineering methodologies, the role is also responsible for the site's facility and capacity planning, provides cost analysis and optimizes capital expenditure to meet business needs.

Key Responsibilities:

• Identify and lead continuous improvement and value improvement projects within the site. Drive operational excellence strategies and deployment to site.

• Formulate the current state and develop the future state end-to-end value stream map. Establish the value stream improvement plan to move the end-to-end value stream from current to future state and ensure deliverables are executed and completed. Define, track and report site specific metrics to senior leadership regularly; elevate issues as necessary. Support and implement site SMART Factory automation and digitalization initiatives.

• Accountable for site equipment capacity and manpower plan. Governance in site equipment capacity and productivity database integrity. Design, develop and implement manufacturing site facility layout. Strategic planning initiatives for capacity expansion, space, equipment and people for productivity and cost improvement within the site.

• Deploy or perform method engineering analysis - process design, lead time analysis, site manufacturing pull and flow optimization. Develop, update, and maintain site standard hours and standard yields.

• Work as change agent with site stakeholders to build continuous improvement mindset and culture. Expand knowledge and adoption of Lean and Six Sigma methodologies to site employees and leadership. Conduct problem solving methodologies training and coaching.

• Support the development of Strat Plan and Annual Operating Plan. Provides cost analysis and return on investment calculations associated with CAPEX projects.

• Other incidental duties

Education and Experience:

• Bachelor's Degree in in Engineering or Scientific field

• 8 years hands-on experience managing projects of increasing complexity and project management experience required

• 6 years experience in the medical device industry preferred

Additional Skills:

• Software Competence: AutoCAD, MS Office, Microsoft Project, Visio Professional, MiniTab, Clarizen

• Knowledge in FDA Regulations in Medical Devices and ISO13485

• Statistical Techniques and Applications

• A3 Thinking and Problem Solving

• Industrial Engineering, Cost Analysis.

• Attention to Details, Highly Organized, Analytical and Critical Thinking, Consultative

• Ability to manage competing priorities in a fast paced environment. Multi-Tasking and Manage Competing Priorities, Simplify Complex Issues into Actionable Items.

• Ability to interact professionally with all organizational levels

• Excellent documentation and communication skills and interpersonal relationship skills including negotiation, collaboration and relationship management skills

• Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing

• Ability to work in a team environment, including frequent inter-organizational and outside customer contacts Cross Functional Team Leadership, Business Acumen

• Represents organization in providing solutions to difficult technical issues associated with specific projects

• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control